Perspectives on Living with Chronic Spontaneous Urticaria: From Onset through Diagnosis and Disease Management in the US.

Chronic spontaneous urticaria is challenging to manage and substantially affects quality of life. This US, non-interventional qualitative study examined patients' clinical journeys and emotional burden from symptom onset through disease management. Chronic spontaneous urticaria patients participated in interviews and completed diaries focusing on disease and treatment history/perspectives, impact on personal/family life, and relationships with physicians/other healthcare providers. Physicians were interviewed about their views on disease management and patient care. Twenty-five patients, previously or currently receiving chronic spontaneous urticaria treatment(s), and 12 physicians participated. Key stages following symptom onset were identified: Crisis (associated with feelings of torment/disorientation/shock); Searching for answers (puzzlement/frustration/anxiety); Diagnosis (relief/satisfaction/fear/isolation); and Disease management (frustration/hope/powerlessness). Findings revealed patients' perceptions and experiences of chronic spontaneous urticaria, including living with a 'skinemy', experiencing their 'own personal hell' and feeling 'like an experiment'. Awareness of unmet needs in patient care/management identified in this study may ultimately improve patient support and enhance physicians' understanding of disease burden.

More than a decade follow-up in patients with severe or difficult-to-treat asthma: The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) II.

BACKGROUND: The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR I) study demonstrated high morbidity in patients with severe or difficult-to-treat asthma despite standard-of-care treatment. OBJECTIVE: We sought to determine the long-term natural history of disease and outcomes in patients in TENOR I after more than a decade. METHODS: TENOR I was a multicenter observational study (2001-2004) of 4756 patients with severe or difficult-to-treat asthma. TENOR II was a follow-up study of TENOR I patients using a single cross-sectional visit in 2013/2014. Overall, the sites participating in TENOR II originally enrolled 1230 patients in TENOR I. Clinical and patient-reported outcomes were assessed, including very poorly controlled asthma based on National Heart, Lung, and Blood Institute guidelines. RESULTS: A total of 341 (27.7%) patients were enrolled in TENOR II and were representative of the TENOR I cohort. The most frequent comorbidities were rhinitis (84.0%), sinusitis (47.8%), and gastroesophageal reflux disease (46.3%). Mean percent predicted prebronchodilator and postbronchodilator FEV1 were 72.7% (SD, 21.4%) and 78.2% (SD, 20.7%), respectively. A total of 231 (72.9%) of 317 patients had positive test responses to 1 or more allergen-specific IgEs. The mean blood eosinophil count was 200/µL (SD, 144/µL). Eighty-eight (25.8%) patients experienced an asthma exacerbation in the prior 3 months requiring hospital attention, oral corticosteroids, or both. More than half (197/339 [58.1%]) had very poorly controlled asthma. Medication use suggested undertreatment. CONCLUSION: TENOR II provides longitudinal data to characterize disease progression, heterogeneity, and severity in patients with severe or difficult-to-treat asthma. Findings show continued morbidity, including a high degree of comorbid conditions, allergic sensitization, exacerbations, and very poorly controlled asthma, including reduced lung function.

Asthma control and disease burden in patients with asthma and allergic comorbidities.

OBJECTIVE: To assess asthma control and associations with health-related quality of life (HRQoL) and economic outcomes among patients with asthma and allergic comorbidities treated with inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) combination therapy. METHODS: Data from the 2011-2013 US National Health and Wellness Survey were used to identify patients with asthma currently treated with ICS and LABA combination therapy (N = 1923). Patients were included if they self-reported a physician diagnosis of asthma and at least one allergic/asthma-related comorbid condition (e.g., nasal allergies, atopic dermatitis). Asthma Control Test scores categorized patients as very poorly (scores ≤ 15; 29.3%), not well (16-19; 25.1%), or well controlled (20-25; 45.7%). Outcomes included HRQoL (SF-36v2; SF-12v2), work productivity and activity impairment, healthcare utilization (HRU), and annual indirect and direct costs. Generalized linear models, controlling for covariates, examined whether outcomes differed by asthma control. RESULTS: Over half of the patients had very poorly or not well-controlled asthma (54.4%). Patients with very poorly controlled versus well-controlled asthma reported significantly greater decreases in HRQoL, greater overall work impairment, and higher HRU (all, p < 0.05). Very poorly controlled patients incurred over double the indirect costs and nearly one and a half times the direct and total costs of well-controlled patients. CONCLUSIONS: Increasing level of asthma control was related to improved HRQoL and lower costs. The considerably high prevalence of uncontrolled asthma among patients on ICS and LABA suggests poor treatment adherence or unmet needs in current treatment and may require step-up therapy in appropriate patients according to clinical guidelines.

Asthma control, lung function, symptoms, and corticosteroid sparing after omalizumab initiation in patients with allergic asthma.

BACKGROUND: Omalizumab is approved in patients with moderate-to-severe allergic asthma with symptoms uncontrolled, despite the mainstay therapy. OBJECTIVE: Electronic medical records (EMR) were used to increase the knowledge of omalizumab effectiveness in a real-world setting. METHODS: Patients with uncontrolled moderate-to-severe allergic asthma, ages ≥12 years old, initiated on omalizumab (index date), with ≥12 months of pre- and postindex data, were identified in an EMR data base. An Asthma Control Test score (≥20 is considered well controlled), forced expiratory volume in 1 second as a percentage of the predicted value (<80% considered below normal), symptoms, and oral corticosteroid (OCS) and inhaled corticosteroid (ICS) use were compared in the 12-month post- versus the preindex period with univariate generalized estimating equations adjusted for repeated measurements. RESULTS: A total of 208 patients (mean ± standard deviation[SD] age, 41 ± 19 years; 64.9% women; 71.2% white; and with a mean ± SD serum total immunoglobulin E level of 455.4 ± 644.7 IU/mL) were identified. In the post- versus preindex period, the patients were significantly more likely to have well-controlled asthma (odds ratio [OR] 1.72 [95% confidence interval {CI}, 1.11-2.64]) and less likely to have a lung function value below normal (nonsignificant) after omalizumab initiation. The patients experienced significantly less coughing (OR 0.66 [95% CI, 0.49-0.91]), shortness of breath (OR 0.60 [95% CI, 0.44-0.83]), and wheezing (OR 0.59 [95% CI, 0.43-0.81]), with no improvement in chest tightness. A significantly lower likelihood of new OCS prescriptions (OR 0.58 [95% CI, 0.41-0.82]) was observed. A lower likelihood of new high- and medium-dose ICS prescriptions was nonsignificant. CONCLUSION: Omalizumab was associated with beneficial effects on asthma control and symptoms, and the likelihood of requiring new OCS prescriptions. An observed trend of improved lung function and lower likelihood of requiring high- and medium-dose ICS did not reach statistical significance.

Disease Burden and Long-Term Risk of Persistent Very Poorly Controlled Asthma: TENOR II.

BACKGROUND: Severe/difficult-to-treat disease occurs in 5% to 10% of patients with asthma, but accounts for more than 50% of related economic costs. Understanding factors associated with persistent very poorly controlled (VPC) asthma may improve outcomes. OBJECTIVE: To characterize persistent VPC asthma after more than 10 years of standard of care. METHODS: The Epidemiology and Natural history of asthma: Outcomes and treatment Regimens (TENOR) II (N = 341) was a multicenter, observational study of patients with severe/difficult-to-treat asthma with a single, cross-sectional visit more than 10 years after TENOR I. Persistent VPC asthma was defined as VPC asthma at TENOR I and TENOR II enrollment; without VPC asthma was defined as well- or not well-controlled asthma at either or both visits. Multivariable logistic regression assessed long-term predictors of persistent VPC asthma using TENOR I baseline variables. RESULTS: Of 327 patients, nearly half (48.0%, n = 157) had persistent VPC asthma. Comorbidities and asthma triggers were more frequent in patients with persistent VPC asthma than in patients without VPC asthma. Total geometric mean IgE was higher in patients with persistent VPC asthma (89.3 IU/mL vs 55.7 IU/mL); there was no difference in eosinophil levels. Lung function was lower in patients with persistent VPC asthma (mean % predicted pre- and postbronchodilator FEV1, 63.0% vs 82.8% and 69.6% vs 87.2%, respectively). Exacerbations in the previous year were more likely in patients with persistent VPC asthma (29.7% vs 9.0%, respectively). Predictors of persistent VPC asthma were black versus white race/ethnicity, allergic trigger count (4 vs 0), systemic corticosteroid use, and postbronchodilator FEV1 (per 10% decrease). CONCLUSIONS: The burden of persistent VPC asthma is high in severe/difficult-to-treat disease; management of modifiable risk factors, maximization of lung function, and trigger avoidance may improve outcomes.

Exploring the real-world profile of refractory and non-refractory chronic idiopathic urticaria in the USA: clinical burden and healthcare resource use.

Introduction: Chronic idiopathic/spontaneous urticaria (CIU/CSU) is a debilitating skin condition that is burdensome for patients and healthcare providers. We aimed to describe clinical characteristics, consultation patterns and healthcare resource utilization in real-world US patients with refractory and non-refractory CIU/CSU. Methods: Data was collected from the Adelphi Real World 2015 Urticaria Disease Specific Programme. Physicians completed patient record forms (PRFs) for the next four patients consulting with non-refractory CIU/CSU and the next six with refractory CIU/CSU; patients were considered refractory if symptomatic and on treatment step ≥2. The same patients were asked to complete patient self-completion (PSC) forms describing how CIU/CSU affected them. Results: Seventeen physicians (15 allergists; 2 dermatologists) completed 184 PRFs (108 refractory CIU/CSU; 76 non-refractory CIU/CSU); 140 patients completed PSC forms (93 refractory CIU/CSU; 47 non-refractory CIU/CSU). Mean time from first consultation to diagnosis was 13.5 (SD 28.3) weeks; mean time from diagnosis to first treatment was 16.0 (SD 37.9) weeks. Patients with refractory CIU/CSU were more likely to initially consult primary care physicians than those with non-refractory CIU/CSU (51% and 28%, respectively). The most common symptoms were itching, sleep problems and anxiety/distress, affecting 75%, 23% and 18%, respectively. Patient-perceived disease severity was greater than physician-perceived severity (refractory CIU/CSU kappa 0.1512; non-refractory CIU/CSU 0.1590). Conclusions: Patients with CIU/CSU in this real-world study - particularly those with refractory CIU/CSU - were slow to receive specialist care and had substantial symptom burdens; patient-physician perception of disease severity was discordant. Earlier diagnosis of CIU/CSU may lead to timely use of CIU/CSU therapies.

Humanistic Burden of Refractory and Nonrefractory Chronic Idiopathic Urticaria: A Real-world Study in the United States.

PURPOSE: Chronic idiopathic urticaria (CIU) is a debilitating skin condition that can profoundly affect patients' quality of life. This study explored the impact of refractory and nonrefractory CIU on patients in the real-world setting in the United States. METHODS: Data were collected from the Adelphi Real World 2015 Urticaria Disease-Specific Programme. Physicians completed patient record forms (PRFs) for 4 consecutive patients consulting with nonrefractory CIU and 6 patients with refractory CIU. The PRF included information on patient characteristics, medication, and disease severity; physicians were asked about the impact of CIU on patients, and to rate their satisfaction with patients' treatment (scale, 1-7 [1 = extremely dissatisfied and 7 = extremely satisfied]). The same patients were asked to complete a patient self-completion form (PSC). This included questions regarding how CIU affected their everyday life and their satisfaction with and understanding of their condition and medications. The PSC included a number of patient-reported outcomes measures: the Dermatology Life Quality Index (scored from 0 to 30, with higher scores indicating greater impact), the Work Productivity and Activity Impairment (4 scores calculated [absenteeism, presenteeism, work productivity loss, and activity impairment], each scored from 0% to 100% after transformation, with higher scores indicating greater impairment), and the Jenkins Sleep Scale (assessed over 30 days; scored from 0 to 20, with higher scores indicating greater sleep disturbance). Completion of the PSC was voluntary. FINDINGS: Seventeen physicians completed a total of 184 PRFs (108 for patients with refractory CIU; 76 for those with nonrefractory CIU); 140 of these 184 patients completed a PSC form (93 with refractory CIU; 47 with nonrefractory CIU). Overall, 26% of the entire population (30% of patients with refractory CIU and 17% with nonrefractory CIU) reported that skin symptoms had a great effect on their lives (Dermatology Life Quality Index score ≥11). Sleep problems were common: mean Jenkins Sleep Scale scores were 7.8 overall (8.1 for patients with refractory CIU and 7.2 for those with nonrefractory CIU). Overall work impairment was 19% in the overall population, with similar values in refractory and nonrefractory patients (18% and 20%, respectively). Physician satisfaction with disease control was not high, with physicians reporting a mean score of 4.8 on a 7-point scale. Twenty-one percent of patients were extremely dissatisfied, very dissatisfied, or dissatisfied with their treatment, and 52% believed better control could be achieved. IMPLICATIONS: The humanistic burden of CIU is high. There is clearly a need for better management of CIU to improve outcomes for patients.

Description of Baseline Characteristics of Pediatric Allergic Asthma Patients Including those Initiated on Omalizumab.

BACKGROUND: Indication of omalizumab in the United States was recently extended to include pediatric (6-11 years) uncontrolled moderate-to-severe allergic asthma patients. OBJECTIVE: The purpose of this study was to describe baseline characteristics of this population from a real-world dataset. METHODS: Allergic asthma patients and uncontrolled moderate-to-severe allergic asthma patients, aged 6-11 years, were identified in the Allergy Partners Network Electronic Medical Records (2007-2016). The index date for allergic asthma patients was the latest between the second asthma-related visit and the allergic status confirmation. Uncontrolled moderate-to-severe allergic asthma patients were stratified into omalizumab-exposed (index date) or omalizumab-unexposed (index date randomly generated) groups. Characteristics were evaluated during the 12-month preindex period. RESULTS: A total of 5806 allergic asthma, 37 omalizumab-exposed, and 2620 omalizumab-unexposed patients were selected (mean age approximately 9 years). Allergic asthma and omalizumab-unexposed patients were predominantly white (70.2% and 61.2%) whereas the majority of omalizumab-exposed were African Americans (62.2%). Mean immunoglobulin E was 782.0 IU/ml in allergic asthma patients (available in 2.2%), 1134.4 IU/ml in omalizumab-exposed (available in 100.0%), and 746.1 IU/ml in omalizumab-unexposed (available in 3.1%). Allergic asthma patients were less severe than omalizumab-exposed and omalizumab-unexposed based on the forced expiratory volume in 1 s as a percentage of predicted value (FEV1% predicted) and the Childhood Asthma Control Test (C-ACT). FEV1% predicted was below normal (<80%) in 42.4% of omalizumab-exposed and 39.1% of omalizumab-unexposed patients, also 63.6% of omalizumab-exposed and 46.7% of omalizumab-unexposed had uncontrolled asthma (C-ACT score <20). In African American omalizumab-exposed patients, FEV1% predicted was below normal in 47.6% and 55.0% had uncontrolled asthma. CONCLUSIONS: In a real-world setting, pediatric patients with uncontrolled moderate-to-severe allergic asthma have a significant disease burden as shown by high rates of poor lung function, disease control, and symptoms. Currently available treatments could help improve disease management in this population.

Real-World Characteristics and Treatment Patterns in Patients with Urticaria Initiating Omalizumab in the United States.

BACKGROUND: Omalizumab is indicated for the management of chronic idiopathic urticaria (CIU) in patients aged 12 years or older with persistent hives that are not adequately controlled by H1 antihistamines. While its safety and efficacy in CIU patients have been evaluated in multiple clinical trials, real-world use of omalizaumab in CIU has not been well characterized. OBJECTIVE: To assess demographics, clinical characteristics, and treatment patterns of CIU patients who initiated omalizumab to better understand the usage of this agent in CIU management in the real world. METHODS: This retrospective cohort study used medical and pharmacy claims data in the United States from the HealthCore Integrated Database to identify patients with CIU newly treated with omalizumab (≥ 4 omalizumab claims within 6 months of the initial claim) between March 21, 2014, and October 31, 2015 (study intake period). The index date was defined as the date of the first claim for omalizumab during the study intake period. Demographic and clinical characteristics were described for patients treated with omalizumab, as were treatment patterns associated with omalizumab and concomitant medications associated with CIU treatment. Descriptive and inferential statistics were reported. The Kaplan-Meier method was used to examine omalizumab treatment patterns. RESULTS: This study included 298 omalizumab-treated patients (mean [SD] age of 43.5 [13.64] years; 70.8% female); approximately 84% were seen by an allergist/immunologist. All patients had ≥ 12 months of continuous enrolment and a subset of 138 patients had ≥ 18 months of follow-up. For patients with ≥ 12 months of post-index follow-up, 12.1% (n = 36), 28.5% (n = 85), and 32.9% (n = 98) discontinued omalizumab within the 6-month, 12-month, and the entire post-index periods (mean 530 days), respectively; the mean number of days patients were continuously treated with omalizumab was 443.1 (95% CI = 425.0-461.3); the probabilities of continuous treatment (95% CI) were 0.879 (0.836-0.911), 0.711 (0.656-0.759), and 0.647 (0.585-0.703) for the 6-, 12-, and 18-month post-index periods, respectively. For the 98 patients who discontinued omalizumab during the entire post-index period, 28.6% restarted omalizumab after the first discontinuation within the post-index period (mean time from first discontinuation to first restart=329 days). Use of medications such as oral corticosteroids, montelukast, cyclosporine, and prescription H1 and H2 antihistamines decreased during the 1- to 6-month and 7- to 12-month post-index periods compared with those within the 6-month pre-index period. CONCLUSIONS: In this cohort of CIU patients who were newly prescribed omalizumab, the majority were treated by allergists/immunologists as expected, and approximately 60% of patients continued on therapy beyond 18 months. Concomitant medication use decreased after omalizumab initiation. These data on the real-world use of omalizumab for CIU may help to better inform decision-making processes for health care payers by quantifying omalizumab and concomitant medication treatment patterns over a longer time frame relative to previous studies. DISCLOSURES: This study was sponsored by Novartis Pharmaceuticals, which provided funding support for the conduct of the study. Kavati, Ortiz, and Paknis are employees of Novartis Pharmaceuticals. Ke, Wertz, Huang, Wang, Willey, and Stephenson are employees of HealthCore, an independent research organization that received funding from Novartis Pharmaceuticals for the conduct of this study. Beck is an employee of the University of Rochester Medical Center, who was under contract with Novartis Pharmaceuticals to provide consulting services to this study, and reports grants from Genentech, outside the currently submitted work. Bernstein is affiliated with Bernstein Clinical Research Center, which was under contract with Novartis Pharmaceuticals to provide consulting services to this study, and reports receiving grants and personal fees from Novartis Pharmaceuticals, grants and personal fees from Genentech outside of the submitted work, and is an author on the Joint Task Force for Practice Parameters for Urticaria and the GALEN international guidelines for urticaria under preparation. Selected study data were presented in a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 22nd Annual International Meeting on May 20-24, 2017, in Boston, MA. A poster based on this dataset was presented at the 2017 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting on October 26-30, 2017, in Boston, MA.

Real-world treatment patterns and outcomes of omalizumab use in patients with chronic idiopathic urticaria.

OBJECTIVE: To examine treatment patterns, treatment response, and demographic and clinical characteristics of patients with chronic idiopathic urticaria (CIU) newly initiated on omalizumab therapy in real-world practice in the US. METHODS: This retrospective observational cohort study used US claims data from the HealthCore Integrated Research Database (HIRD®) augmented with medical record data to identify CIU patients newly-treated with omalizumab (≥4 omalizumab claims within 6 months of initial claim; index date = first omalizumab claim date) between March 21, 2014 and October 31, 2015 and with ≥6 months pre- and ≥12 months post-index health plan eligibility. Study outcomes were captured from medical records for up to 12 months pre-index and up to 24 months post-index. Descriptive statistics were reported. RESULTS: This study consisted of 88 patients with a mean (SD) age of 43.4 (± 13.46) years, 68.2% were female, and 36 patients had ≥18 months post-index eligibility. Among 69 patients with documented index dose, 75.4% received omalizumab 300 mg and 69.6% remained on index dose throughout follow-up. For 52 patients with documented index dosing frequency, 96.2% had every 4-week dosing frequency. Among 86 patients with omalizumab documentation, 83.7% reported CIU improvement after omalizumab initiation and 24.4% discontinued omalizumab. For all patients, the proportion using oral corticosteroids (OCS) decreased pre- to post-index (52.3% vs 39.8%). Similar results were observed for patients with ≥18 months post-index eligibility. CONCLUSIONS: In this real-world analysis, the majority of patients remained on omalizumab for ≥12 months, and had a positive response. OCS use decreased following omalizumab initiation.

Real-World Characteristics and Treatment Patterns in Patients with Urticaria Initiating Omalizumab in the United States.

BACKGROUND: Omalizumab is indicated for the management of chronic idiopathic urticaria (CIU) in patients aged 12 years or older with persistent hives that are not adequately controlled by H1 antihistamines. While its safety and efficacy in CIU patients have been evaluated in multiple clinical trials, real-world use of omalizaumab in CIU has not been well characterized. OBJECTIVE: To assess demographics, clinical characteristics, and treatment patterns of CIU patients who initiated omalizumab to better understand the usage of this agent in CIU management in the real world. METHODS: This retrospective cohort study used medical and pharmacy claims data in the United States from the HealthCore Integrated Database to identify patients with CIU newly treated with omalizumab (≥ 4 omalizumab claims within 6 months of the initial claim) between March 21, 2014, and October 31, 2015 (study intake period). The index date was defined as the date of the first claim for omalizumab during the study intake period. Demographic and clinical characteristics were described for patients treated with omalizumab, as were treatment patterns associated with omalizumab and concomitant medications associated with CIU treatment. Descriptive and inferential statistics were reported. The Kaplan-Meier method was used to examine omalizumab treatment patterns. RESULTS: This study included 298 omalizumab-treated patients (mean [SD] age of 43.5 [13.64] years; 70.8% female); approximately 84% were seen by an allergist/immunologist. All patients had ≥ 12 months of continuous enrolment and a subset of 138 patients had ≥ 18 months of follow-up. For patients with ≥ 12 months of post-index follow-up, 12.1% (n = 36), 28.5% (n = 85), and 32.9% (n = 98) discontinued omalizumab within the 6-month, 12-month, and the entire post-index periods (mean 530 days), respectively; the mean number of days patients were continuously treated with omalizumab was 443.1 (95% CI = 425.0-461.3); the probabilities of continuous treatment (95% CI) were 0.879 (0.836-0.911), 0.711 (0.656-0.759), and 0.647 (0.585-0.703) for the 6-, 12-, and 18-month post-index periods, respectively. For the 98 patients who discontinued omalizumab during the entire post-index period, 28.6% restarted omalizumab after the first discontinuation within the post-index period (mean time from first discontinuation to first restart=329 days). Use of medications such as oral corticosteroids, montelukast, cyclosporine, and prescription H1 and H2 antihistamines decreased during the 1- to 6-month and 7- to 12-month post-index periods compared with those within the 6-month pre-index period. CONCLUSIONS: In this cohort of CIU patients who were newly prescribed omalizumab, the majority were treated by allergists/immunologists as expected, and approximately 60% of patients continued on therapy beyond 18 months. Concomitant medication use decreased after omalizumab initiation. These data on the real-world use of omalizumab for CIU may help to better inform decision-making processes for health care payers by quantifying omalizumab and concomitant medication treatment patterns over a longer time frame relative to previous studies. DISCLOSURES This study was sponsored by Novartis Pharmaceuticals, which provided funding support for the conduct of the study. Kavati, Ortiz, and Paknis are employees of Novartis Pharmaceuticals. Ke, Wertz, Huang, Wang, Willey, and Stephenson are employees of HealthCore, an independent research organization that received funding from Novartis Pharmaceuticals for the conduct of this study. Beck is an employee of the University of Rochester Medical Center, who was under contract with Novartis Pharmaceuticals to provide consulting services to this study, and reports grants from Genentech, outside the currently submitted work. Bernstein is affiliated with Bernstein Clinical Research Center, which was under contract with Novartis Pharmaceuticals to provide consulting services to this study, and reports receiving grants and personal fees from Novartis Pharmaceuticals, grants and personal fees from Genentech outside of the submitted work, and is an author on the Joint Task Force for Practice Parameters for Urticaria and the GALEN international guidelines for urticaria under preparation. Study concept and design were primarily contributed by Kavati, Ortiz, and Paknis, with assistance from the other authors. Huang, Wang, and Ke took the lead in data collection, with assistance from Wertz, Willey, and Stephenson. Data interpretation was performed by Ke, Wertz, and Willey, assisted by the other authors. The manuscript was written by Stephenson, Ke, and Wang, along with Willey, Wertz, and Huang, and revised by Bernstein and Beck, with assistance from the other authors. Selected study data were presented in a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 22nd Annual International Meeting on May 20-24, 2017, in Boston, Massachusetts. A poster based on this dataset was presented at the 2017 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting on October 26-30, 2017, in Boston, Massachusetts.